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Crispr Therapy Shown to Reduce Harmful Gut Microbes

E. coli bacteria illustration

E. coli bacteria (Volunteer7, Wikimedia Commons.

31 May 2023. A clinical trial shows an oral therapy with engineered viruses delivers precise gene-edited payloads to reduce E. coli communities in the gut with no serious adverse effects. Initial findings from the trial were released today on the web site of Snipr Biome ApS in Copenhagen, Denmark, developer of the experimental drug code-named Snipr001, and are not yet peer-reviewed.

Snipr Biome is a biotechnology enterprise that designs gene-edited treatments for infections in the microbiome, communities of bacteria and other microorganisms in the gut and elsewhere in the body. The company’s process employs the genome editing technique Crispr, short for clustered regularly interspaced short palindromic repeats. Crispr is based on bacterial defense mechanisms that use RNA to identify and monitor precise locations in DNA.

Snipr Biome says its process delivers DNA sequences edited with Crispr and Cas editing enzymes, which code for therapeutic peptides, short strings of amino acids, to kill harmful gut bacteria and prevent infections, while sparing beneficial microbes. The company’s delivery mechanisms are either engineered bacteriophages, or phages, natural viral adversaries of bacteria, or bacterial conjugation, where genetic materials are transferred from one bacterium to another through direct contact.

Developed for high-risk cancer patients

In this case, Snipr Biome designs Snipr001, its lead product, with four engineered phages to deliver edited DNA to kill harmful strains of Escherichia coli or E. coli bacteria in the gut. The company says it developed Snipr001 for patients with blood-related cancers like leukemia or lymphoma at high risk of infection, by destroying harmful and antibiotic-resistant E. coli in the gut before reaching the blood stream. The usual treatments, says Snipr Biome, are broad spectrum antibiotics such as fluoroquinolone that are already used excessively, contributing further to the global problem of antibiotic-resistant microbes.

The early-stage clinical trial enrolled 36 healthy adult volunteers, randomized two-to-one to receive one of three Snipr001 dose levels or a placebo, once a day for seven days. The study team looked mainly for adverse effects from the treatments, for up to 35 days after the seven-day treatment regimen. The researchers also tracked participants for another 152 days, for any lingering adverse effects. And the team took fecal samples from participants before, during, and after giving Snipr001, to gauge gut E. coli levels in participants as well as the feasibility of collecting these data. Science & Enterprise reported on the start of the trial in Apr. 2022.

Snipr Biome says participants report only mild to moderate adverse effects from Snipr001 treatments, with no serious adverse effects nor any withdrawals from the trial. The company does not specify the adverse effects experienced by participants. Snipr Biome also reports evidence of Snipr001 in fecal samples taken from participants, as well as lower E. coli levels in the samples of Snipr001 recipients. However, the company does not report any numerical data.

Christian Grøndahl, CEO and co-founder of Snipr Biome says in a company statement that the study provides “clinical validation for this innovative treatment.” Grøndahl adds, “With the combined killing effects of bacteriophages and Crispr-Cas technology, Snipr001 has demonstrated the ability to target and eliminate antibiotic-resistant E. coli strains in the gut, providing a safe alternative to traditional treatments that do not work against antibiotic-resistant strains, while sparing the rest of the gut microbiome.”

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